PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS— 510(k) K945617

Substantially Equivalent

Pharma-Plast Intl. A/S

FDA 510(k) clearance K945617 for PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS, Substantially Equivalent on 1995-02-13. Applicant: Pharma-Plast Intl. A/S.

Clearance details

Applicant: Pharma-Plast Intl. A/S
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1994-11-15
Decision date: 1995-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lynge, DK

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.